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• Frequently Asked Questions about Generic Drugs
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Generic Drugs: Questions and Answers
What Are Generic Pharmaceuticals?
A generic drug is a copy that is the same as a brand-name drug in
dosage, safety, strength, how it is taken, quality, performance and
intended use.
Are generic drugs as safe as brand-name drugs?
Yes. FDA requires that all drugs be safe and effective. Since
generics use the same active ingredients and are shown to work the same
way in the body, they have the same risks and benefits as their brand-name
counterparts.
Are generic drugs as strong as brand-name drugs?
Yes. FDA requires generic drugs to have the same quality, strength,
purity and stability as brand-name drugs.
Do generic drugs take longer to work in the body?
No. Generic drugs work in the same way and in the same amount of time as brand-name drugs.
Why are generic drugs less expensive?
Generic drugs are less expensive because generic manufacturers don't
have the investment costs of the developer of a new drug. New drugs
are developed under patent protection. The patent protects the
investment—including research,
development, marketing, and promotion—by
giving the company the sole right to sell the drug while it is in
effect. As patents near expiration, manufacturers can apply to the FDA
to sell generic versions. Because those manufacturers don't have the same
development costs, they can sell their product at substantial
discounts. Also, once generic drugs are approved, there is greater competition,
which keeps the price down. Today, almost half of all prescriptions
are filled with generic drugs.
Are brand-name drugs made in more modern facilities than generic
drugs?
No. Both brand-name and generic drug facilities must meet the same
standards of good manufacturing practices. FDA won't permit drugs
to be made in substandard facilities. FDA conducts about 3,500 inspections
a year to ensure standards are met. Generic firms have facilities
comparable to those of brand-name firms. In fact, brand-name firms
are linked to an estimated 50 percent of generic drug production.
They frequently make copies of their own or other brand-name drugs
but sell them without the brand name.
If brand-name drugs and generic drugs
have the same active ingredients, why do they look different?
In the United States, trademark laws do not allow a generic drug to
look exactly like the brand-name drug. However, a generic drug must
duplicate the active ingredient. Colors, flavors, and certain other
inactive ingredients may be different.
Does every brand-name drug have a generic counterpart?
No. Brand-name drugs are generally given patent protection for 20 years from
the date of submission of the patent. This provides protection for
the innovator who laid out the initial costs (including research,
development, and marketing expenses) to develop the new drug. However,
when the patent expires, other drug companies can introduce competitive
generic versions, but only after they have been thoroughly tested
by the manufacturer and approved by the FDA.
What is the best source of information about generic drugs?
Contact your physician, pharmacist, or insurance company for
information on your generic drugs.
Switching to Generics Drugs
Are you thinking of switching to use generic pharmaceuticals? Health authorities recommend that patients contact their doctor before switching to generic drugs.
Many brand name drugs have equivalent generic drugs available. In the U.S., almost half of all prescriptions filled in 2002 were for generic pharmaceuticals. Over the next two years it is expected that more than two thirds of all prescriptions will be filled with generic drugs (3). These generic pharmaceuticals will not only be supplied on generic prescriptions. This is because in the U.S. most states allow pharmacists to substitute generic drugs on prescriptions with the doctor’s approval even though a brand name product may have initially been prescribed.
If after seeking your doctor’s approval you decide to purchase generic drugs through Value Pharmaceuticals, you can expect to receive the same clinical effect as with their brand name counterparts, but for a considerably reduced cost!
However, there are a small number of brand name drugs with which great care should be taken when substituting generic pharmaceuticals. These are drugs that have what is termed a ‘narrow therapeutic index’. This means that for these drugs a small variation in dose can cause problems, such as too little effectiveness or too many side effects. In these few cases, a patient should only switch after consulting with their doctor and then do so only with his or her approval and close supervision.
International Nonproprietary Names
An 'International Nonproprietary Name' (INN) is the official chemical name (nonproprietary name) given to a pharmaceutical substance as designated by the World Health Organisation (WHO). The proprietary name is the brand name.
i.e; Prozac = proprietary name,
fluoxetine hydrochloride = nonproprietary name.
The intention of an INN is to ensure there is a standard name for each chemical substance across the world. Occasionally, the United States and/or Britain may designate their own nonproprietary name for a particular substance, rather than adhering to the INN. In such instances, the nonproprietary name may be referred to as a 'United States Adopted Name' (USAN) or as a 'British Approved Name' (BAN). Sometimes the USAN or the BAN can differ from the INN.
SOURCE: FDA: "Frequently Asked Questions about Generic Drugs."
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